Clinical trials: HER2 Low Metastatic Breast Cancer
Metastatic Breast Cancer, ER-positive Breast Cancer
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative…
- Conditions
- Metastatic Breast Cancer, ER-positive Breast Cancer, Luminal B, Her2 Enriched
- Trial name
- DISCORDANT (NCT06585969)
- Testing
- Trastuzumab deruxtecan (T-DXd), Ribociclib with ET, Abemaciclib with ET
- Sponsor
- Danish Breast Cancer Cooperative Group
Breast Cancer, HER2-low Breast Cancer
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab…
- Conditions
- Breast Cancer, HER2-low Breast Cancer, Metastatic Breast Cancer, HER2-negative Breast Cancer
- Trial name
- TRADE DXd (NCT06533826)
- Testing
- Trastuzumab Deruxtecan, Datopotamab Deruxtecan
- Where
- 11 sites in United States
- Volunteers
- 357 people
- Sponsor
- Ana C Garrido-Castro, MD
HER2-negative Breast Cancer, Metastatic Breast Cancer
Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer.
The primary objetive is to assess the capacity of the RAD51-foci score to predict the efficacy of olaparib in BRCA1/2, PALB2 or RAD51C/D mut advanced breast cancer (cohort 1).
- Conditions
- HER2-negative Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer
- Trial name
- RADIOLA (NCT05340413)
- Testing
- Olaparib
- Where
- 5 sites in Spain
- Volunteers
- 65 people
- Sponsor
- SOLTI Breast Cancer Research Group
Neoplasms, Breast
A Study to Examine the Effects of Low and High-fat Meals on Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients
This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of lapatinib administered after a high or low-fat meal.
- Trial name
- NCT00821054
- Testing
- Lapatinib
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 24 people
- Sponsor
- GlaxoSmithKline
Breast Cancer
SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.
- Trial name
- NCT05814354
- Testing
- SHR-A1811, Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
- Where
- China
- Volunteers
- 551 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Neoplasms, Breast Neoplasms
Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)
The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer.
- Conditions
- Neoplasms, Breast Neoplasms, Breast Cancer
- Trial name
- THYME (NCT00900627)
- Testing
- AZD8931, Paclitaxel
- Where
- 38 sites in Belgium, Brazil and 12 more
- Volunteers
- 330 people
- Sponsor
- AstraZeneca
HER2 Positive Untreated Metastatic Breast Cancer, Asymptomatic or Low Symptomatic Brain Metastasis in Breast Cancer
Intrathecal Pertuzumab and Trastuzumab in Patients With New Untreated Asymptomatic or Low Symptomatic Brain Metastasis in HER2 Positive Breast Cancer
The purpose of this research study is to determine how well pertuzumab and trastuzumab works in treating breast cancer that has spread to the brain.
- Trial name
- NCT02598427
- Testing
- Pertuzumab, Trastuzumab
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Kimberly Blackwell
Locally Advanced or Metastatic Breast Cancer
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive…
- Trial name
- NCT06439771
- Testing
- YL202 should be intravenously infused
- Where
- China
- Volunteers
- 180 people
- Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
Unresectable Breast Cancer, Metastatic Breast Cancer
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low…
- Conditions
- Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-positive Breast Cancer
- Trial name
- HER-TEMPO (NCT06386263)
- Testing
- Trastuzumab deruxtecan
- Where
- Canada
- Volunteers
- 22 people
- Sponsor
- AstraZeneca
Breast Cancer
Deescalation of Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk
Hormone therapy is recommended for five years in all patients with hormone receptor-positive breast cancer, but there is no consensus on its duration in low-risk tumours and especially in postmenopausal women.
- Trial name
- LESS (NCT05297617)
- Testing
- Anti-aromatase inhibitor
- Where
- 2 sites in France
- Volunteers
- 696 people
- Sponsor
- UNICANCER
Esophageal Neoplasms, Gastric Neoplasms Malignant
[68Ga]Ga-ABY-025 PET for Quantification of HER2-status in Solid Tumors
The goal of this phase II clinical trial is to improve the selection of patients with solid tumors who would benefit from effective treatment with HER2 targeted drugs.
- Conditions
- Esophageal Neoplasms, Gastric Neoplasms Malignant, Breast Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT05619016
- Testing
- [68Ga]Ga-ABY-025 PET, Biopsy and analysis of HER2 expression
- Where
- Sweden
- Volunteers
- 72 people
- Sponsor
- Karolinska University Hospital
Breast Cancer Metastatic
A Phase II Study of SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases
A prospective, single-arm study to explore the efficacy and safety of SHR-A1811 combined with radiotherapy in patients with HER2-positive or HER2-low brain metastases
- Trial name
- NCT06975462
- Testing
- SHR-A1811 and radiotherapy
- Volunteers
- 30 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Breast Cancer With Low Expression of HER2
ARX788 in Breast Cancer With Low Expression of HER2
A Phase 2 Study of ARX788 in unresectable and/or metastatic breast cancer with low expression of HER2.
- Trial name
- NCT05018676
- Testing
- ARX788
- Where
- China
- Volunteers
- 54 people
- Sponsor
- Fudan University
HER2-negative
NIS Study Determining Prevalence of HER2-low in Metastatic Breast Cancer Patients
This noninterventional, multicenter,retrospective study has been proposed to estimate the prevalence, clinicopathological characteristics,treatment patterns and clinical outcomes of human epidermal growth factor receptor 2…
- Trial name
- iRetroBC (NCT06131424)
- Where
- 31 sites in Argentina, Brazil and 11 more
- Volunteers
- 1,151 people
- Sponsor
- AstraZeneca
Breast Cancer, Metastatic Breast Cancer
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer
- Trial name
- SERIES (NCT06263543)
- Testing
- Sacituzumab govitecan
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- Reshma L. Mahtani, D.O.
Metastatic Breast Cancer
A Phase II Study of SSGJ-612 Plus a HER2-Targeted ADC in HR-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer
This study is a phase II clinical trial of SSGJ-612 combined with a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) in patients with hormone receptor (HR)-positive, HER2-low or HER2-ultralow…
- Trial name
- NCT07757230
- Testing
- SSGJ-612 (HER2-targeted antibody), HER2-targeted ADC
- Where
- China
- Volunteers
- 87 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Breast Cancer
Axillary Nodal Burden in HER2+ and TNBC
This study aimed to evaluated rates of pathologic axillary nodal metastasis in patients with with early-stage HER2-positive BC or TNBC who had clinically node-negative status on preoperative ultrasonography and underwent upfront…
- Trial name
- NCT07211451
- Testing
- Breast conserving surgery with axillary surgery
- Where
- South Korea
- Volunteers
- 1,571 people
- Sponsor
- Gangnam Severance Hospital
Locally Advanced or Metastatic Breast Cancers
Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.
This is a multicenter, prospective, non-randomized, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer…
- Trial name
- TDXdose (NCT07195344)
- Testing
- Pharmacokinetics blood samples
- Where
- 10 sites in France
- Volunteers
- 210 people
- Sponsor
- Institut Claudius Regaud
HER2-low Breast Cancer
Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study
This is a multicenter, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of disitamab vedotin in combination with bevacizumab in patients with HER2-low advanced or metastatic breast cancer who have…
- Trial name
- NCT07446452
- Testing
- Disitamab Vedotin (RC48), Bevacizumab
- Where
- China
- Volunteers
- 37 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
HER2-low Hormone Receptor Positive Breast Cancer
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse…
- Trial name
- NCT06832202
- Testing
- HLX22, Trastuzumab Deruxtecan
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Henlius Biotech